Picore
K-Number: K212082 · 2021-10-06
ApplicantBio-Med USA, Inc.
Decision Date2021-10-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Picore is a medical device manufactured by Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2021-10-06 under approval number K212082. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Picore?
Picore is a medical device that received FDA 510(k) clearance on 2021-10-06. It is manufactured by Bio-Med USA, Inc.. The 510(k) number is K212082.
When was Picore approved by the FDA?
Picore received FDA 510(k) clearance on 2021-10-06, under approval number K212082.
What company makes Picore?
Picore is manufactured by Bio-Med USA, Inc..
What is the FDA product code for Picore?
The FDA product code for Picore is GEX. This falls under the Gastroenterology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.